A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides

NCT00389311 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-04-01

No results posted yet for this study

Summary

The purpose of this study is to determine if detectable changes in permeability of the lining of the colon are caused by either application of HIV microbicide gels or medical procedures, such as flexible sigmoidoscopy.

Conditions

  • HIV Infections

Interventions

DRUG

Normosol-R

DRUG

Nonoxynol-9

PROCEDURE

Gastrointestinal instrumentation

Sponsors & Collaborators

Principal Investigators

  • Edward Fuchs, PA-C, MBA · The Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-02-29
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00389311 on ClinicalTrials.gov